A postgraduate research project training opportunity is currently available with the Federal Drug Administration's (FDA) Division of Biology, Chemistry, and Materials Science (DBCMS) Office of Science and Engineering Laboratories (OSEL). This project will be served with the Center for Devices and Radiological Health (CDRH) in Silver Spring, MD.

OSEL performs product testing; develops reliable standardized test methods for CDRH and industry use; performs anticipatory scientific investigations on emerging technologies; contributes laboratory data to national and international standards used in CDRH decision making; provides scientific and technical training for CDRH staff members; and maintains laboratory collaborations and relationships with scientific researchers in academia and other Federal laboratories. OSEL also coordinates and oversees CDRH activities that support the development of national and international standards.

CDRH aims to protect and promote the public health by: assuring that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products; providing consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products CDRH oversees; and  facilitating medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

This project will address the need for high performance liquid chromatography (HPLC) data and will test methods essential for determining the amount of drug lost prior to and during drug-coated angioplasty balloon (DCB) inflation in blood vessels. The team objective is to conduct research in support of the regulatory and public health mission of the FDA that involves angioplasty balloons that are inserted into blood vessels blocked by plaque and then expanded to remove the blockage. Restenosis (reblockage) occurs at rates of 40-50% due to cell proliferation within 3-6 months after a balloon angioplasty. DCBs deliver drugs to the blood vessel lumen to minimize cell proliferation and restenosis.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The initial appointment is for 10-13 months, but may be renewed upon recommendation of FDA contingent on the availability of funds. The participant will receive a stipend of between $35,000 and $52,000 commensurate with education level and experience. Proof of health insurance is required for participation in this program. The appointment is full-time at CDRH in the Silver Spring, Maryland, area. Participants do not become employees of FDA or the program administrator, and there are no fringe benefits paid.

We are seeking a chemist with a strong laboratory working experience and who:

• Has a BS or MS degree in Chemistry within 5 years.
• Has strong laboratory working experience with High Performance Liquid Chromatography.
• Is capable of handling tools and instrument set-ups.
• Is capable of performing multiple laboratory experiments, calculations, and analyzing data.

• Degree: Bachelor's Degree, Master's Degree, or Doctoral Degree received within the last 60 month(s).
• Discipline(s):
  • Chemistry and Materials Sciences (1 )
  • Engineering (4 )
  • Life Health and Medical Sciences (1 )